Regulatory Affairs Director

VitalConnect

Responsible for regulatory affairs activities such as regulatory submissions at Vital Connect Inc. Assuring compliance with medical device regulations and assisting with post-market activities.

Posted 6/2/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $150,000 - $175,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for regulatory affairs activities such as regulatory submissions, registrations and listings.
Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.
Assist in creation and maintenance of regulatory files.
Assist with post-market activities.
Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries.
Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
Maintain regulatory files.
Maintain and update regulatory authorizations, such as 510(k)s, medical device licenses, certificates, and CE Technical Files for EU, etc.
Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
Support approval in other regions as required.
Assist in preparing response to regulatory authorities’ questions within assigned timelines.
Stay abreast of regulatory procedures and changes in regulatory climate.
Assess device related incidents/complaints for medical device reporting requirements.
Compile and submit reportable events to relevant regulatory authorities in timely manner.
Handle recalls and field actions, if required.
Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

Requirements

What you’ll need

Bachelor’s degree in Engineering or Science or related scientific discipline.
4 years minimum experience in a medical device environment
Working knowledge of regulations, standards and guidelines related to regulatory affairs
Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
Excellent written and verbal communication skills with the ability to listen, articulate and advocate
Proactive, high performance, result oriented and manage projects with ethical integrity
Technical system skills (e.g. MS office applications, databases, efficient online research)
Manage multiple projects and deadlines
Ability to identify compliance risks and escalate when necessary
Demonstrate both creative and critical thinking skills.

Benefits

Comp & perks

medical
dental
401K retirement plan

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionsmedical device regulationsregulatory files maintenance510(k) submissionsCE Technical Filesdevice listingsmedical device reportingproduct labeling compliancetechnical document writinganalytical skills

Soft Skills

written communicationverbal communicationproactiveresult orientedproject managementethical integritycreative thinkingcritical thinkinglistening skillsadvocacy